Reported May 13, 2015 · Terminated
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 419 West Ave · Stamford, CT · 06902-6343
Is this the product you have?
- Aspire HD, Full Field Digital, System, x-Ray, Mammographic
- ModelFOR MS-1000. A mammography system used for screening and diagnosis of breast cancer
- Lot codes and dates
- Serial Number26320119
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
User Manual lacks a description for handling some errors even though the system can be recovered from such errors
This product could cause temporary or reversible health problems — stop using it.
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